This study investigates if a new medical device, which injects contrast media and flushing solution into humans to increase the visibility of images taken of the human body for diagnostic purposes, is easier to handle, quicker and cheaper than an older injector.
The study compares an investigational injection system (Centargo) for computed tomography (CT) to a currently marketed injection system (Stellant MP) in terms of efficiency, cost, performance and user satisfaction (Part 1). In addition, the reliability of the new injection system Centargo is tested (Part 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
425
Contrast-enhanced computer tomography conducted with Centargo injector
Contrast-enhanced computer tomography conducted with Stellant MP injector
Medscan
Merrylands, New South Wales, Australia
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Setup time of CT systems
Time frame: 1 day
Change time for bottle/ bag containing contrast medium
Time frame: 1 day
Patient setup time for the multi-patient set per day
Time frame: 1 day
Teardown time of CT-system
Time frame: 1 day
Number of multi-patient sets per day
Time frame: 1 day
Total cost for multi-patients set and disposables per patient and day
Time frame: 1 day
Reason for change of multi-patient syringe set for the injection of contrast media prior to expiration at 24 hours
Time frame: 1 day
Volume of unused contrast agent at teardown time
Time frame: 1 day
Volume of unused saline at teardown time
Time frame: 1 day
Flow rate of contrast agent through the injector
Time frame: 1 day
Volume of contrast agent delivered through injector
Time frame: 1 day
Injector-generated pressure
Time frame: 1 day
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Number of automated system alerts
Incl. alerts due to communication loss, pressure limiting, air detection (Centargo only) and a full waste container (Centrago only).
Time frame: 1 day
Radiographer satisfaction with contrast-media injector by study-related questionnaire
Questionnaire contains 14 questions on injectors, disposables and software, pertaining to 5 levels of user satisfaction (´Very easy´ to ´Very hard´). Levels of user satisfaction from different questions are not combined.
Time frame: Up to 4.5 months
Number of errors requiring a CT-system reboot
For Centargo only (Part 2)
Time frame: 1 day